Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

Colonoscope, General & Plastic Surgery

FDA classification

FDA Class 2 ·Colonoscope, General & Plastic Surgery

Over-The-Counter Powered Light Based Laser For Acne

FDA classification

FDA Class 2 ·Over-The-Counter Powered Light Based Laser For Acne

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)